What Is The Difference Between a Glatt and a GEA-Niro Fluid Bed Granulator / Dryer?

Posted by David Watt

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WS093Many clients will come to us and have a specific type of fluid dryer that they’re using at their own facility or the facility at which they get their product manufactured. Typically, the fluid bed dryer will either be manufactured by Glatt or GEA Niro. A common client concern we address involves moving from one brand of FBG/FBD to another. The big question is – what are the main differences between these brands of equipment?

The correct answer is - there really is no difference between them. GEA Niro and Glatt are two different both world leading manufacturer’s of similar types of processing equipment for the production of powders, conglomerates and granulates. Basically, it’s more of a company preference than a performance choice.

Both machines are categorized under the FDA guidance of SUPAC (Scale-Up and Post Approval Changes) IR (immediate release products) and SUPAC MR (modified release products) as granulators and dryers.  As granulators, FBGs are defined as “achieve densification and/or agglomeration with little or no shear by direct granulation fluid atomization and impingement on solids while suspended by a controlled gas stream with simultaneous drying”.  

As dryers, FBD’s are classified as “direct heating fluidized solids beds”. Heat transfer on a fluid bed is accomplished by the contact between the wet solids (your product – spray granulated in the FBG or in a high shear mixer) and hot gases (heated HEPA filtered process air).

Consider The Equipment's Performance Characteristics For Your Production Process

Although different brands of fluid bed granulators / dryers may differ from one another in geometry, or operating pressures, they all operate by the same principals, and under the SUPAC no sub-classes have been identified that would differentiate either machine. The key thing to recognize as a client transferring your process to a contract manufacturer, is that there is no particular need to be alarmed about the brand of equipment to be used in the process. Even though each FBG/FBD installation or brand of machine may appear visually to differ slightly, similarly configured equipment of the same capacity from either manufacturer may be used to accomplish the same process Glatt and GEA-Niro-Aeromatic fluid granulator/dryer equipment are comparable.

Fluid_Bed_DryerWhat is important is to review each piece of equipment for size, and configuration, functionality and the critical operating principles of the equipment design to ensure that the necessary performance targets that for your process can be met. Minor compensations for the differences in the way equipment performs or how the FBG/FBD was installed in different facilities often need to be made. It’s best for the contract manufacturing organization to get an understanding of the client’s product and the processes as they exist and review them step by step. The name on the particular device isn’t what we look at, we examine the performance characteristics of the equipment, for example, the type of spray nozzle used, the solution application rates, the drying times, and bulk product specifications for moisture and particle size. We also examine the size of the equipment. We may have to compensate for some of the individual process parameters that will be used. In the end analysis, it’s all based on equipment function. You have to examine the critical parameters as stated in the production process.

Developing A Feasibility Plan Is Key

One of the most important things to consider is the feasibility study, to ensure you’re able to lift that wet granulate properly, to fluidize it, to determine what your drying time is, how long does it take to meet that loss on drying specification and ensure that fluidization air volume will proper fluidize the granulation to provide even and efficient drying. Too little air volume will cause improper fluidization and uneven drying; too much air volume can cause attrition resulting in fine particles produced and a change in the desired particle size distribution.

As always with a site change, clients need to perform a regulatory review and confirm all proposed changes because there might be something that they will need to address with the regulatory agency they’re working with, be it be the FDA or Health Canada or the European Medicines Agency.

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Topics: Manufacturing Scale-Up

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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